Identity
- Trade Name
- coraCross FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Cora Cross Coronary Crossing Catheter 14X135cm FDA UDI
- Model / Reference
- CRX14135US FDA UDI
- Description
- Cora Cross Coronary Crossing Catheter 14X135cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850025525046 FDA UDI
- 510(k) Number
- FDA Product Code
- DQY FDA 510(k)FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)FDA UDI
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 135 Centimeter FDA UDIGuidewire Diameter — .014 Inch FDA UDI
coraCross by Reflow Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210188 | Class II | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
- FDA Applicant
- Reflow Medical
Sources (2)
- FDA 510(k) K210188 24 fields · synced Jun 18, 2026
- FDA UDI e4bfdff7-0c03-4718-9250-73632b5310ed 36 fields · synced May 27, 2026